STERISPINE CC
K-Number: K162531 · 2016-12-29
ApplicantSafe Orthopaedics
Decision Date2016-12-29
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
STERISPINE CC is a medical device manufactured by Safe Orthopaedics. It received FDA 510(k) clearance on 2016-12-29 under approval number K162531. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the STERISPINE CC?
STERISPINE CC is a medical device that received FDA 510(k) clearance on 2016-12-29. It is manufactured by Safe Orthopaedics. The 510(k) number is K162531.
When was STERISPINE CC approved by the FDA?
STERISPINE CC received FDA 510(k) clearance on 2016-12-29, under approval number K162531.
What company makes STERISPINE CC?
STERISPINE CC is manufactured by Safe Orthopaedics.
What is the FDA product code for STERISPINE CC?
The FDA product code for STERISPINE CC is OVE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.